Evaluating an Insulin Pump for Time in Range (TIR) in Patients with Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-75
SponsorTao Yuan，MD
About this trial
Diabetes mellitus is a metabolic disorder caused by genetic, environmental changes, mental health issues, immune disorders, and other factors. It may occur with or without insulin resistance, insulin secretion defect, or impaired biological function of insulin. The condition is characterized by chronic hyperglycemia and targeted damage to multiple systems and organs. Insulin pump therapy is an advanced method for managing diabetes that mimics the natural secretion of insulin by providing continuous delivery to diabetic patients. Compared to traditional multiple injections, the use of an insulin pump reduces the number of injections required and improves patient compliance and treatment convenience. The medical team can customize the insulin pump treatment based on each patient's specific situation in order to achieve optimal blood sugar control and effectively reduce the risk of complications. In recent years, there has been significant attention given to glucose-in-target time (TIR), which refers to the amount of time blood sugar levels are within a range of 3.9 to 10.0 mmol/L in non-pregnant adults measured either as minutes or as a percentage (%). This clinical trial aims to collect data on using an insulin pump (Model: AR-B200A) combined with a scanning glucose monitoring system (Model: FreeStyle Libre, 20163072472) for continuous subcutaneous insulin infusion in type 1 diabetes patients in order to provide reference for related clinical applications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 8 and 75 years old, regardless of gender;
Subjects with T1DM (including adult occult autoimmune diabetes mellitus (LADA)) who have been judged by investigators to require insulin pump therapy;
Subjects who are able to cooperate with insulin pump therapy and derive weekly data from insulin pump during study treatment;
During the study period, the subject's total daily insulin should be ≥8 units;
Disqualifiers
Hyperglycemia with severe circulatory disorders and shock;
Acute complications of diabetes (such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma);
A history of 2 or more episodes of severe hypoglycemia leading to medical assistance, coma or seizure in the 6 months prior to screening;
The presence of at least 4 hypoglycemic symptoms, occurrence or detection of hypoglycemic events within 1 month before screening;
Trial design
Design model
Single group
Treatments tested in this trial
insulin pump (model: AR-B200A)
DeviceUSE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Insulin pump therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time in range (TIR) at week 4 of treatment
TIR is defined as the percentage (%) of the entire day that is within the target range of blood sugar (3.9 to 10.0 mmol/L) \[1\], measured in minutes. The mean of CGM monitoring for 3 days prior to participation in the V9 visit (week 4 ±3 days of treatment) (excluding the day of follow-up) was used as TIR at week 4 of treatment. The basic principle is to choose 3 days close to the date of the visit. If blood glucose monitoring was not possible for 1 of the 3 days close to the visit date, the data of the previous 1 day was used instead; If blood glucose monitoring was not possible for 2 out of 3 days close to the visit date, data from 2 days ahead was used instead.
Time frame
week 4 ±3 days of treatmentSecondary outcomes
1
Hemoglobin a1c (HbA1c)
HbA1c (%, mmol/mol) and its change from baseline at week 4 and week 1 after treatment were recorded.
Time frame
from baseline at week 4 and week 1 after treatment2
Glycated albumin (GA)
GA (%, g/dL) and its change from baseline at week 1, week 2, week 4 and week 1 after treatment were recorded.
Time frame
from baseline at week 1, week 2, week 4 and week 1 after treatment3
Time in Range (TIR), time below range (TBR), time above range (TAR)
TBR: Time below the blood glucose target range (3.9 to 10.0 mmol/L). TAR: Time above the target blood glucose range (3.9 to 10.0 mmol/L).
Time frame
through study completion, an average of 3 month4
TIR, TBR and TAR all reached the control target
The proportion of subjects whose TIR, TBR and TAR all reached the control goal at week 1, week 2, week 4 and week 1 after treatment was calculated.
Time frame
at week 1, week 2, week 4 and week 1 after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tao Yuan，MD
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Second Xiangya Hospital of Central South University
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: